Apparatus for imparting physician-determined shapes to implantable tubular devices

Abstract

A tubular sleeve is provided for enabling a physician to impart a preselected shape in an implantable tubular device, such as a cardiac lead, a catheter, or some other tubular structure. The sleeve may be deformed by the surgeon before or at the time of implantation to customize the shape of the tubular device to the particular anatomical structures to be encountered by the device. To retain the deformation imparted by the physician, the sleeve may be composed of a heat-sensitive shape-memory material or an elastomeric material provided with a plastically deformable rib.

What is claimed is:  
     
       1. A method for imparting a customized shape to an implantable tubular device specific to the shape requirements of the patient comprising: 
       providing an implantable tubular device;  
       providing a sleeve;  
       sizing at least one section of sleeve to a patient specific length;  
       deforming the section of sleeve to a patient specific bend such that the section of sleeve imparts a new bent shape to the implantable tubular device specific to the shape requirements of the patient, where deforming the section of sleeve occurs at the time of implant; and  
       placing the section of sleeve over the implantable tubular device at a patient specific point.  
     
     
       2. The method of  claim 1  wherein deforming the section of sleeve to a patient specific bend comprises plastically deforming the sleeve to a patient specific bend adapted to conform to a particular anatomical structure. 
     
     
       3. The method of  claim 1  wherein deforming the section of sleeve to a patient specific bend comprises plastically deforming the sleeve to a patient specific bend adapted to conform to a particular anatomical structure, wherein the sleeve is comprised of a shape memory material, and deforming comprises: 
       elevating the shape memory material above a glass transition temperature, the glass transition temperature being above a maximum temperature expected inside a body into which the tubular device is to be placed;  
       deforming the sleeve at the elevated temperature to a patient specific bend adapted to conform to a particular anatomical structure; and  
       returning the sleeve to a temperature below the glass transition temperature to retain the patient specific bend.  
     
     
       4. The method of  claim 1  wherein the sleeve is comprised of a material capable of being hardened by chemical, photo, or thermal stimulation, and wherein deforming the section of sleeve to a patient specific bend comprises: 
       deforming the sleeve to a patient specific bend adapted to conform to a particular anatomical structure; and  
       exposing the sleeve to chemical, photo, or thermal stimulation to retain the patient specific bend to the sleeve.  
     
     
       5. A method for imparting a customized shape to an implantable tubular device specific to the shape requirements of the patient comprising: 
       providing an implantable tabular device;  
       providing a sleeve;  
       sizing at least one section of sleeve to a patient specific length;  
       placing the section of sleeve over the implantable tubular device at a patient specific point; and, subsequently  
       deforming the section of sleeve to a patient specific bend such that the section of sleeve imparts a new bent shape to the implantable tabular device specific to the shape requirements of the patient.  
     
     
       6. The method of  claim 5  wherein the section of sleeve is deformed such that the central axis of the section of sleeve is nonlinear in two dimensions. 
     
     
       7. The method of  claim 5  wherein the section of sleeve is deformed such that the central axis of the section of sleeve is nonlinear in three dimensions. 
     
     
       8. The method of  claim 5  further comprising: 
       the sleeve including a heat sensitive shape memory material deformable to the patient specific bend when heated above the glass transition temperature, capable of retaining the patient specific bend when cooled below the glass transition temperature, the section of sleeve also capable of being restored to its original shape when reheated above the glass transition temperature, the glass transition temperature being above body temperature range; and  
       deforming the section of sleeve including heating the sleeve above the glass transition temperature, bending the section of sleeve to the patient specific bend, and fixing the patient specific bend by cooling the section of sleeve below the glass transition temperature.  
     
     
       9. The method of  claim 5  further comprising: 
       reheating the section of sleeve above the glass transition temperature to restore the section of sleeve to its original shape.  
     
     
       10. The method of  claim 5  wherein the sleeve includes a heat sensitive shape memory polymer. 
     
     
       11. The method of  claim 5  wherein the sleeve includes a heat sensitive shape memory metal. 
     
     
       12. The method of  claim 5  wherein the section of sleeve is heated to reduce the inner diameter. 
     
     
       13. The method of  claim 5  wherein the sleeve includes Nitinol. 
     
     
       14. The method of  claim 5  wherein the sleeve includes a material that hardens upon exposure to chemical, photo, or thermal stimulation and wherein: 
       deforming the section of sleeve includes deforming the section of sleeve to the patient specific bend and exposing the sleeve to heat, chemical or photo stimulation so that it retains the patient specific bend.  
     
     
       15. The method of  claim 14  wherein the sleeve includes a polymeric material. 
     
     
       16. The method of  claim 5  wherein the section of sleeve includes a longitudinal slit to allow the sleeve to be wrapped around the implantable tubular device at the patient specific point. 
     
     
       17. The method of  claim 5  wherein deforming the section of sleeve to a patient specific bend comprises plastically deforming the sleeve to a patient specific bend adapted to conform to a particular anatomical structure. 
     
     
       18. The method of  claim 5  wherein the sleeve is comprised of a shape memory material, and wherein deforming the section of sleeve to a patient specific bend comprises: 
       elevating the shape memory material above a glass transition temperature, the glass transition temperature being above a maximum temperature expected inside a body into which the tubular device is to be placed;  
       deforming the sleeve at the elevated temperature to a patient specific bend adapted to conform to a particular anatomical structure; and  
       returning the sleeve to a temperature below the glass transition temperature to retain the patient specific bend.  
     
     
       19. The method of  claim 5  wherein the sleeve is comprised of a material capable of being hardened by chemical, photo, or thermal stimulation, and wherein deforming the section of sleeve to a patient specific bend comprises: 
       deforming the sleeve to a patient specific bend adapted to conform to a particular anatomical structure; and  
       exposing the sleeve to chemical, photo, or thermal stimulation to retain the patient specific bend to the sleeve.  
     
     
       20. The method of  claim 5  wherein deforming the section of sleeve to a patient specific bend comprises plastically deforming the sleeve to a patient specific bend adapted to conform to a particular anatomical structure. 
     
     
       21. A method for imparting a customized shape to an implantable tubular device specific to the shape requirements of the patient comprising: 
       providing an implantable tubular device;  
       providing a sleeve;  
       sizing at least one section of sleeve to a patient specific length;  
       placing the section of sleeve over the implantable tubular device at a patient specific point;  
       subsequently deforming the section of sleeve to a patient specific bend such that the section of sleeve imparts a newshape to the implantable tubular device specific to the shape requirements of tide patient;  
       the sleeve including a shape memory material;  
       the sleeve having an inner diameter such that the inner diameter provides an interference fit with the tubular device; and  
       deforming the at least one section of sleeve includes cold working the inner diameter of the section of the sleeve such that the section of sleeve will side over the tabular device, heating the section of sleeve above a transition temperature so that the section of sleeve resumes its initial diameter, cooling the section of sleeve below the transition temperature, deforming the sleeve to the patient specific bend, the transition temperature being above body temperature range.  
     
     
       22. A method for imparting a customized shape to an implantable tubular device specific to the share requirements of the patient compromising: 
       providing an implantable tubular device;  
       providing a sleeve;  
       sizing at least one section of sleeve to a patient specific length;  
       deforming the section of sleeve to a patient specific bend such that the section of sleeve imparts a new shape to the implantable tubular device specific to the shape requirements of the patient; and  
       placing the section of sleeve over the implantable tubular device at a patient specific point;  
       wherein the sleeve is comprised of a material capable of being hardened by chemical stimulation, and wherein deforming the section of sleeve to a patient specific bend comprises;  
       deforming the sleeve to a patient specific bend adapted to conform to a particular anatomical structure; and  
       exposing the sleeve to chemical stimulation to retain the patient specific bend to the sleeve.  
     
     
       23. The method of  claim 1  wherein the sleeve is comprised of a material capable of being hardened by photo stimulation, and wherein deforming the section of sleeve to a patient specific bend comprises: 
       deforming the sleeve to a patient specific bend adapted to conform to a particular anatomical structure; and  
       exposing the sleeve to photo stimulation to retain the patient specific bend to the sleeve.  
     
     
       24. A method for imparting a customized shape to an implantable tubular device specific to the shape requirements of the patient comprising: 
       providing an implantable tubular device;  
       providing a sleeve;  
       sizing at least one section of sleeve to a patient specific length;  
       placing the section of sleeve over the implantable tubular device at point;  
       subsequently deforming the section of sleeve to a patient specific bend such that the section of sleeve imparts a newshape to the implantable tubular device specific to the shape requirements of the patient;  
       wherein the sleeve is comprised of a material capable of being hardened by chemical stimulation, and wherein deforming the section of sleeve to a patient specific bend comprises;  
       deforming the sleeve to a patient specific bend adapted to conform to a particular anatomical structure; and  
       exposing the sleeve to chemical stimulation to retain the patient specific bend to the sleeve.  
     
     
       25. A method for imparting a customized shape to an implantable tubular device specific to the shape requirements of the patient comprising: 
       providing an imputable tabular device;  
       providing a sleeve;  
       sizing at least one section of sleeve to a patient specific length;  
       placing the section of sleeve over the implantable tubular device at a patient specific point;  
       subsequently deforming the section of sleeve to a patient specific bend such that the section of sleeve imparts a newshape to the implantable tubular device specific to the shape requirements of the patient;  
       wherein the sleeve is comprised of a material capable of being hardened by photo stimulation, and wherein deforming the section of sleeve to a patient specific bend comprises;  
       deforming the sleeve to a patient specific bend adapted to conform to a particular anatomical structure; and exposing the sleeve to photo stimulation to retain the patient specific bend to the sleeve.